NCT07238413

Brief Summary

We aim to investigate the effects of adding scapular stabilization exercises to the extracorporeal shock wave therapy (ESWT) protocol in the treatment of lateral epicondylitis on pain, muscle strength, functional status, and quality of life.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 4, 2025

Status Verified

October 1, 2025

Enrollment Period

2 months

First QC Date

September 28, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

tennis elbowESWTPainScapular muscle trainingfunctional status

Outcome Measures

Primary Outcomes (6)

  • Pain Assessment: Visual Analog Scale (VAS)

    Pain will be assessed using the Visual Analog Scale (VAS). On this scale, a score of 0 indicates "no pain" and a score of 10 represents "the worst possible pain." Participants will be asked to mark their perceived pain level on a 10 cm horizontal line, anchored at 0 and 10. The distance from the left end of the line to the participant's mark will be measured in centimeters and recorded. The VAS is a valid and reliable tool for pain assessment. Pain will be evaluated separately at rest, during activity, and at night.

    From baseline assesment to the end of treatment at 8 weeks

  • Scapular Position Assessment: (Lateral Scapular Slide Test)

    The distance between the inferior angle of each scapula and the nearest spinous process will be measured in three different test positions on both sides using a measuring tape. A side-to-side difference of 1.5 cm or more is considered a positive result and indicates scapular asymmetry.

    From enrollment to the end of treatment at 8 weeks

  • Pressure Pain Threshold Measurement

    Measurements will be performed with a digital algometer while the participant is seated, with the shoulder abducted at 30°, the elbow flexed at 90°, and the forearm, wrist, and hand supported. Pressure pain threshold will be measured over the lateral epicondyle. Three measurements will be taken at each point using the 1 cm² tip of the algometer, and the average of these three measurements will be recorded.

    From enrollment to the end of treatment at 8 weeks

  • Grip Strength

    Patients' grip strength will be assessed using a Jamar hand dynamometer, following the protocol recommended by the American Society of Hand Therapists.

    From enrollment to the end of treatment at 8 weeks

  • Muscle Strength

    Muscle strength of the lower and middle trapezius, serratus anterior, and wrist extensor muscles will be measured using a handheld dynamometer before and after the treatment.

    0 and 8 week

  • Functional Status

    PRTEE (Patient-Rated Tennis Elbow Evaluation): The PRTEE is designed specifically for lateral epicondylitis and consists of 15 items divided into 3 subscales. Each item is scored from 0 to 10. Higher scores on the scale indicate worse functional status. (The subscales assess pain, specific activities, and general daily activities.) JHand: JHand evaluates the functional status of the upper extremity and consists of 25 items. Each item is scored on a scale from 0 (no difficulty) to 4 (unable to perform). Higher scores on this scale also indicate worse functional status.

    From enrollment to the end of treatment at 8 weeks

Other Outcomes (1)

  • Health-Related Quality of Life

    baseline and at the end of the 8-week intervention period.

Study Arms (2)

control group

ACTIVE COMPARATOR

Participants in the control group will receive a protocol consisting of extracorporeal shock wave therapy (ESWT), stretching exercises for the extensor carpi radialis brevis (ECRB) muscle and wrist extensor muscles, as well as isometric, eccentric, and concentric strengthening exercises targeting the wrist extensors. The ESWT will be applied once a week, for a total of 5 sessions

Other: ESWT + Scapular stabilization exercise program

Study group

EXPERIMENTAL

Participants in the study group will follow a treatment protocol consisting of extracorporeal shock wave therapy (ESWT) - 5 sessions, once per week - combined with stretching exercises for the extensor carpi radialis brevis (ECRB) and wrist extensor muscles, strengthening exercises for the wrist extensors, and an additional scapular stabilization exercise program. This combined program will be performed twice per week for a duration of 8 weeks. The scapular stabilization component will include strengthening exercises targeting the lower and middle trapezius and serratus anterior muscles. The program will consist of scapular clock exercises, wall push-up exercises, and wall slide or ball slide exercises performed on a wall.

Other: ESWT + Scapular stabilization exercise program

Interventions

Participants in the study group will follow a treatment protocol consisting of extracorporeal shock wave therapy (ESWT) - 5 sessions, once per week - combined with stretching exercises for the extensor carpi radialis brevis (ECRB) and wrist extensor muscles, strengthening exercises for the wrist extensors, and an additional scapular stabilization exercise program. This combined program will be performed twice per week for a duration of 8 weeks. The scapular stabilization component will include strengthening exercises targeting the lower and middle trapezius and serratus anterior muscles. The program will consist of scapular clock exercises, wall push-up exercises, and wall slide or ball slide exercises performed on a wall.

Study groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65 years.
  • Diagnosed with lateral epicondylitis by a physician, with positive Mill's, Cozen's, or Thomsen tests.
  • Experiencing pain and tenderness over and around the lateral epicondyle for at least 3 months, with symptoms exacerbated by resisted elbow extension, wrist extension, gripping, and supination.
  • Willing to voluntarily participate in the study.

You may not qualify if:

  • Individuals with serious systemic or cardiovascular diseases that contraindicate exercise of the hand and upper extremity.
  • Those diagnosed with upper extremity entrapment neuropathies.
  • Patients with a diagnosis of malignancy.
  • Individuals with open wounds on the hand or upper extremity.
  • Pregnant women or those suspected of being pregnant.
  • Patients who have received physiotherapy and/or injection treatments within the last 6 weeks.
  • Patients with diabetes mellitus, rheumatologic diseases, or neurological disorders.
  • Individuals who have undergone upper extremity surgery or had an upper extremity fracture within the last 6 months.
  • Patients with coagulation disorders or those receiving anticoagulant therapy.
  • Individuals with conditions causing degenerative changes in the hand and upper extremity.
  • Patients diagnosed with carpal tunnel syndrome, cubital tunnel syndrome, thoracic outlet syndrome, medial epicondylitis, radiohumeral bursitis, or cervical disc pathology.
  • Patients using analgesic or anti-inflammatory medications other than acetaminophen (paracetamol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Büşra Yalçın

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis ElbowPain

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

büşra yalçın, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking was applied at the outcome assessment level. The independent outcome assessor was blinded to participants' group allocation throughout data collection, ensuring unbiased evaluation of study endpoints.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomized Study model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

September 28, 2025

First Posted

November 20, 2025

Study Start

November 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 4, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations